Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
1
paragangliomas
The main study aim of the study is to examine the feasibility of detecting PGLs using 68Ga-exendin-4 PET/CT.
Key facts
- Sponsor
- Stichting Radboud universitair medisch centrum
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 27 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516755-40-00
- EudraCT number
- 2021-000194-93
- ClinicalTrials.gov
- NCT05418907
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Diagnosis
The main study aim of the study is to examine the feasibility of detecting PGLs using 68Ga-exendin-4 PET/CT.
Secondary objectives 5
- Determining the optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT.
- Comparing semi-quantitative imaging parameters (SUV, tumor-to-background ratio, contract-to-noise ratio) between 68Ga-exendin-4 PET/CT and SSTR PET/CT
- Assessing the correlation between GLP-1R expression and tracer uptake in PGLs
- Correlating quantitative imaging results and IHC data
- Assessing safety / side effects of 68Ga-exendin-4 in patients with PGL
Conditions and MedDRA coding
paragangliomas
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- • Proven sympathetic PGL with a single tumor detected using standard diagnostic imaging
- • No evidence of metastatic disease
- • CT and SSTR PET/CT performed (golden standard diagnostic imaging)
- • Scheduled for surgery
- • Able to sign informed consent
Exclusion criteria 6
- • Breast feeding
- • Pregnancy or the wish to become pregnant within 1 month
- • Calculated creatinine clearance below 40ml/min
- • Evidence of other malignancy than PGL in conventional imaging (suspicious liver, bone and lung lesions)
- • Age < 18 years
- • Not able to sign informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Detection rate of PGLs (paragangliomas) using 68Ga-exendin-4 PET/CT
Secondary endpoints 4
- optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT
- Comparison of quantitative imaging paramters (SUV, tumor-to-background ratio, contract-to-noise ratio) between Optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT, 18F-FDG PET and SSTR PET
- correlation between GLP-1R expression and tracer uptake in the PGLs
- Correlation quantitative imaging results and IHC data to the genetic origin of the PGLs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP23185750 · ATC
- Active substance
- Exenatide
- Substance synonyms
- EXENDIN-4, LY-2148568, HIS-GLY-GLU-GLY-THR-PHE-THR-SER-ASP-LEU-SER-LYS-GLN-MET-GLU-GLU-GLU-ALA-VAL-ARG-LEU-PHE-ILE-GLU-TRP-LEU-LYS-ASN-GLY-GLY-PRO-SER-SER-GLY-ALA-PRO-PRO-PRO-SER-NH2, AC-2993
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 100 MBq megabecquerel(s)
- Max total dose
- 100 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ01 — EXENATIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA/OD/0000028068
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- C-terminal modification with Lys, chelator NODAGA attached via AHX spacer for labelling with Ga68
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud universitair medisch centrum
- Sponsor organisation
- Stichting Radboud universitair medisch centrum
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Sevilay Tokgöz
Public contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Sevilay Tokgöz
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Radboud universitair medisch centrum Stichting
Medical imaging, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-09-27 | 2024-09-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516755-40-00 | 2 |
| Recruitment arrangements (for publication) | K1_blank_document_Recruitment_arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF first 5 patients | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-02 | Netherlands | Acceptable with conditions 2024-09-27
|
2024-09-27 |